DEPO MEDROL 40 MGML

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

METHYLPREDNISOLONE ACETATE

متاح من:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC رمز:

H02AB04

الشكل الصيدلاني:

SUSPENSION FOR INJECTION

تركيب:

METHYLPREDNISOLONE ACETATE 40 MG/ML

طريقة التعاطي:

PERIARTICULAR, I.M, INTRA-ARTICULAR, INTRA-LESIONAL, INTRABURSAL, INTRARECTAL INSTILLATION, SOFT TISSUES

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PFIZER INC, USA

المجموعة العلاجية:

METHYLPREDNISOLONE

المجال العلاجي:

METHYLPREDNISOLONE

الخصائص العلاجية:

For the treatment of conditions responsive to steroid injection therapy.

تاريخ الترخيص:

2022-03-31

نشرة المعلومات

Depo Medrol PIL WC 070923
1
2023-008803
4
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
DEPO MEDROL
® 40 MG/ML
SUSPENSION FOR INJECTION
Each 1 ml of solution for injection contains:
methylprednisolone acetate 40 mg
Inactive ingredients and allergens: See section 2 under ‘Important
information about some of
this medicine’s ingredients’ and section 6 “Further
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor,
pharmacist, or nurse.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For the treatment of medical conditions responsive to steroid
injection therapy.
THERAPEUTIC GROUP: injectable corticosteroids
Corticosteroids are produced naturally in the body and are important
for many body functions.
THE MEDICINE IS INTENDED FOR intramuscular (I.M.),
intra-articular, intra-lesional, periarticular
administration, intrarectal instillation, intrabursal administration
or administration into soft
tissues.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You think you have ever suffered from an ALLERGIC reaction, or any
other reaction
after receiving Depo Medrol 40 mg/ml or any other medicine containing
a
corticosteroid or any of the other ingredients in this medicine (see
section 6). An
allergic reaction may cause a skin rash or redness, swelling of the
face or lips or
shortness of breath.
•
You get a RASH, or another symptom of an infection.
•
You have recently had, or are about to have any VACCINATION.
CONTACT YOUR DOCTOR IMMEDIATELY IF ONE OR MORE OF THE ABOVE APPLIES TO
YOU.
DO NOT INJECT THIS MEDICINE:
•
into the ACHILLES TENDON (which is located behind the ankle joint), or
•
directly into A VE

خصائص المنتج

Depo-Medrol 40 MG/ML LPD CC 210923
2021-0068475 ;2021-0068476
PAGE 1 OF 21
DEPO-MEDROL
® 40 MG/ML
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
DEPO- MEDROL
®
40 MG/ml
Suspension for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methylprednisolone acetate 40 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for Injection.
White, sterile, aqueous suspension .
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of conditions responsive to steroid injection
therapy.
A.
FOR INTRAMUSCULAR ADMINISTRATION
Methylprednisolone acetate (Depo-Medrol) is not suitable for the
treatment of acute life
threatening conditions. If a rapid hormonal effect of maximum
intensity is required, the l.V
administration of highly soluble methylprednisolone sodium succinate
(Solu-Medrol) is
indicated.
When oral therapy is not feasible and the strength, dosage form, and
route of administration of
the drug reasonably lend this preparation to the treatment of the
condition, the intramuscular
use of Depo-Medrol is indicated as follows: ANTI-INFLAMMATORY TREATMENT
1. Rheumatic disorders
As adjunctive therapy for short-term administration (to tide the
patient over an acute
episode or exacerbation) in:
Psoriatic arthritis
Ankylosing spondylitis.
For the following indications, preference should be given to in situ
administration if possible:
Post-traumatic osteoarthritis
Synovitis of osteoarthritis
Rheumatoid arthritis, including juvenile rheumatoid arthritis
(selected cases
may require low- dose maintenance therapy)
Depo-Medrol 40 MG/ML LPD CC 210923
2021-0068475 ;2021-0068476
PAGE 2 OF 21
Acute and subacute bursitis
Epicondylitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
2.
Collagen diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
3. Dermatological diseases
Pemphigus
Bullous dermatitis herpetiformis (sulfone is the drug of